Airway intubation device

ABSTRACT

An airway intubation device having a one-piece molded body of biocompatible material with an ergonomically designed hand piece for left hand manipulation. The body includes a cap piece and linear-curved-linear insertion piece having a channel in one side thereof for insertion of an endotracheal tube. The channel has a wide entry portal disposed ahead of the hand piece so that a clinician may load the channel with a tube while the insertion piece is in the mouth of the patient without having to view the entry portal. The device includes illumination means and viewing means comprising an eye piece or a video display unit mounted to the cap piece so that a clinician can view the insertion of the tube between the vocal cords of a patient without contact.

RELATED APPLICATIONS

This application claims the benefit of provisional patent applicationNo. 60953992 filed in the United States Patent and Trademark Office onAug. 4, 2007.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to medical devices and more specifically to animproved airway intubation device.

2. Background of the Invention—the Problem to be Solved

In both acute-care medicine and as part of delivering a generalanesthetic for an operative procedure it is often necessary to insert abreathing tube into the airway of a living organism, most often a human,but in some cases this can also apply to pets, livestock and otheranimals. This procedure is called endotracheal intubation. A variety oftools exist for performing this procedure, which is usually performed byhighly trained professionals in a hospital, or pre-hospital setting.Most intubations are performed with direct laryngoscopy, using a devicecalled a direct laryngoscope, which incorporates a curved or straightblade. The laryngoscope is inserted into the patient's mouth and throatby the clinician who is generally standing at the patient's head. Thelaryngoscope blade controls the tongue and other internal structures tohelp directly visualize the vocal cords (glottic inlet). The vocal cordsmark the entry point to the wind pipe (trachea) and lungs and representthe target destination through which the breathing tube (endotrachealtube) is advanced.

When intubating a human, the goal is to place an endotracheal tubebetween the vocal cords (the glottic inlet) into the upper trachea toallow oxygen to be supplied to the lungs. It is preferable that thevocal cords be seen during intubation as they are the best guide toentry into the trachea and lungs, as opposed to incorrect entry to theesophagus and stomach. Unrecognized failure to correctly place anendotracheal tube into the trachea can result in a failure ofoxygenation, and the patient's death.

In expert hands, endotracheal intubation using a direct laryngoscopewill be easy 95% of the time. A real challenge remains in that it takes50 or more intubations to achieve a 90% success rate. In an attempt todeal with this learning curve issue and to help manage difficult cases,so-called ‘alternative intubation’ devices have been developed. Somesuch scopes feature an “L”-shaped blade and use fiber- or video-opticsfor visualization. Using these devices, visualization of the vocal cordsis often made easier but actual delivery of the breathing tube(endotracheal tube, ETT) between the cords into the windpipe (trachea)of the patient often remains difficult. When using these devices, notinfrequently, during navigation of the ETT to and through the vocalcords, forward advancement of the ETT can be impeded by ‘hang-up’ on theright vocal cord. In addition, sporadic cases of trauma to the softpalate have been reported.

In another prior art device, a rounded tubular “J”-shaped blade was usedincorporating a tube delivery channel to help with tube delivery.However, while the delivery channel was an attempt to deal with thechallenges of tube placement, success was often impaired because: (a)the rounded (tubular) blade was too narrow to control the tongue andsoft tissues well, so that one could often ‘get lost’ and not see thetarget vocal cords, and (b) the tube emerged from the delivery channelheading in an angle that often resulted in the tube being directedincorrectly into the esophagus and not the trachea.

There is a continued need for an intubation device for use by cliniciansthat is highly reliable, relatively easy to use and is able to linkvisualization of vocal cords directly with endotracheal tube placement.

SUMMARY OF THE INVENTION

Our invention is an airway intubation device comprising a cap piece, ahand piece and an insertion piece molded into a single rigid body from asuitable biocompatible material. The hand piece is ergonomically adaptedfor left hand manipulation and comprises a first end, a second end, avertical axis, an oval cross-section for hand clasping, a finger contactportion, a palm contact portion and a thumb contact portion permittingfine control to be exerted on the device with minimum force. The fingercontact portion comprises a train of alternating ridges and valleysadapted for placement between a clinician's index, middle, ring andsmall fingers for even force distribution. The palm contact portion isadapted for full contact with a clinician's palm so that manipulativeforces can be transmitted to the device through the entire surface ofthe clinician's palm. The thumb contact portion is adapted for contactwith the side of the clinician's thumb so that manipulative forces canbe exerted on the thumb contact portion.

The insertion piece comprises, from top to bottom, a first linearportion having a first axis, contiguous with a curved portion,contiguous with a second linear portion having a second axis. The firstaxis is inclined in a positive direction from the vertical axis. Thesecond axis and the vertical axis intersect at a first predeterminedangle which is between 91 degrees and 120 degrees and preferably about107 degrees.

The second linear portion comprises a truncated tip, a top surface, abottom surface and a flange member extending around the truncated tip toavoid tissue damage during intubation. The top surface of the insertionpiece has a centre-line and a raised element disposed along and over thecentre-line for helping to situate the blade in a midline positionduring intubation by frictional contact with the median sulcus (of thetongue). The first axis and the second axis form a second predeterminedangle between 80 and 89 degrees and preferably about 85 degrees.

The device is molded from a suitable biocompatible material designed fortranslucence so that light is able to disperse through it. This improvesillumination of the intubation operation and guidance of the insertionpiece into the trachea of the patient. The device can also be fabricatedfrom other materials such as stainless steel.

Within the insertion piece there is an open endotracheal tube channelhaving a wide entry portal and an exit portal. The channel has atubular-shaped cross-section providing at least 200 degrees ofcircumferential coverage for an inserted endotracheal tube. The entryportal is wider than the endotracheal tube to aid ease of entry of theETT into the channel during intubation. The open slot to the channel,which runs it full length, is designed to be narrower than the outerdiameter of the ETT, to ensure the ETT remains within the channel duringadvancement.

The airway intubation device includes an illumination system and animage viewing system with an image gathering component permitting theclinician to view insertion of an endotracheal tube into a patient'strachea. The illumination system comprises at least one LED lampdisposed adjacent to the exit portal for illuminating the patient'svocal cords and surrounding areas. In another example the illuminationsystem comprises an LED lamp located within the hand piece with lightbeing transmitted through the insertion piece using fiberoptic bundles(light guide) to a portal adjacent to the image viewing system. Theimage viewing system may be a viewing piece (eyepiece) on the cap piececonnected by fiberoptic cable (image gathering component) to a viewingportal adjacent to the exit portal. In another example, the imagegathering component of the viewing system may be a camera adjacent tothe exit portal connected to a video display screen attached to the cappiece.

The focal path of the image gathering system is designed to guide theendotracheal tube through the centre of the vocal cords.

In one example of the invention, the video display includes ananatomically correct aiming reticle representing the vocal cords so thatthe clinician can guide the tube between the cords while viewing thevideo display screen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of the head and neck of a patient showing partsrelevant to intubation.

FIG. 2 is a top view showing placement of a clinician relative to apatient during intubation.

FIG. 3 is a view of a patient's mouth as viewed by a clinician showingparts relevant to intubation.

FIG. 4 is a right side view of one example of the invention.

FIG. 5 is a right side view of one example of the invention in a lefthand grasp.

FIG. 6 is a cross-section of the hand piece of one example of theinvention.

FIG. 7 is a front perspective view of one example of the invention.

FIG. 8 is a left side view of one example of the invention.

FIG. 9 is a top view of the insertion piece of one example of theinvention.

FIG. 10 is an enlarged view of the second linear segment of theinsertion piece of one example of the invention.

FIG. 11 is the same view as FIG. 5.

FIG. 12 is a view of an endotracheal tube of the type used with allexamples of the invention.

FIG. 13 is an enlarged view of the exit portal of the channel of oneexample of the invention.

FIG. 14 is a cross-sectional view of an endotracheal tube exiting thechannel of one example of the invention.

FIG. 15 illustrates a side view of one example of the invention with aneye piece.

FIG. 16 illustrates a side view of another example of the invention witha video display screen.

FIG. 17 illustrates the aiming reticle of one example of the invention.

FIG. 18 and FIG. 19 illustrate the aiming offset of one example of theinvention (FIG. 19) compared to a prior art device (FIG. 18).

FIG. 20 illustrates another example of the invention with removableinsertion pieces.

DETAILED DESCRIPTIONS OF EXAMPLES OF THE INVENTION

The process and principals of endotracheal intubation are well known.Referring to FIG. 1, there is shown a cross-section of a human head (10)and neck (12) to illustrate the anatomy relevant to intubation. There isshown the nose (14) and nasal passage (16). The palate (18) separatesthe mouth (20) and oral cavity (24) from the nasal passages. The upper(26) and lower (28) teeth and tongue (30) are also shown. Duringbreathing, air travels down the windpipe or trachea (32) into the lungs.Food and water travel down the esophagus (34) to the stomach. To avoidchoking, the epiglottis (36) closes the trachea when swallowing andopens again to permit breathing. The vocal cords (38) are located belowthe epiglottis and mark the entry point into the trachea. All of theseairway soft-tissues are vulnerable to damage during intubation. Themajor challenge in performing endotracheal intubation relates to theneed to see around the corner created in part by the tongue andepiglottis. The tongue and the epiglottis must be engaged with someforce to manipulate and control both. With most intubation devices,during intubation, the tongue must be compressed out of the way and theepiglottis must be lifted to expose the vocal cords, through which theendotracheal tube is placed into the trachea.

Referring to FIG. 2, during the intubation process, the clinician (40)is located at the head of the patient (42). Throughout thisspecification I will use the term “clinician” to mean any medical caregiver authorized to perform tracheal intubation.

Endotracheal intubation may be required as part general anesthesia foran operative procedure or as part of resuscitative efforts in managingacutely ill patients. Regardless of the indication, there is a need foran intubation device that is easy to use and permits accurate intubationwithout damaging the parts of the mouth or throat. Referring to FIG. 3,the clinician views the mouth (44) of the patient from an upside-downperspective. The tongue (46) must be controlled, the mouth may beclosed, teeth (48) may block entry into the oral cavity (49) and can bedamaged with instrumentation. An anatomical feature of the tongue whichwill be referred to later in this document is the mid-line groove (52)or median sulcus.

Referring now to FIG. 4, there is shown a side view of the inventionwhich is an airway intubation device (100) comprising a hand piece(102), an insertion piece (104) and a cap piece (106). In one version,the cap piece, hand piece and the insertion piece comprise a rigidsingle molded body. The body is molded from a suitable durablebiocompatible material.

Referring to FIG. 5 which is a side view of the device (100) grasped bya left hand (108) the device (100) is adapted for single left hand (108)manipulation.

Referring to FIGS. 4, 5 and 6 the hand piece (102) comprises a first end(120) and a second end (122), an axis (124) and an oval cross-section(126) (FIG. 4, Section A-A). The hand piece, as illustrated in FIG. 4,is adapted for clasping and so further comprises a finger contactportion (128), a palm contact portion (130) and a thumb contact portion(132). The hand piece permits fine manipulation control of the device ina forward-backward, side-to-side and rotational direction about axis(124) during an intubation process.

The device (100) finger contact portion (128) comprises a train ofalternating ridges (130) and valleys (133). The ridges (130) are adaptedfor placement between the index (134), middle (136), ring (138) andsmall finger (140) respectively for even distribution of force exertedby the hand (108) on the hand piece (102) for manipulation with minimumforce. The palm contact portion (130) is adapted for full palm (142)contact so that manipulative forces can be transmitted to the devicethrough the entire surface of the hand (108). The thumb contact portion(132) is adapted for contact with the side of the thumb (144) so thatside-to-side forces can be exerted on the pad for maneuvering thedevice. The hand piece is designed for optimal biocompatibility with awide variety of human hands. Above the thumb contact portion (132) is aridge (135) that is adapted to prevent the hand from slipping from thehand piece when the device is being lifted in a vertical direction.

The vertical axis of the hand piece (124) and the first axis (168) ofthe second linear portion (166) of insertion piece (104) form apredetermined angle (148) so that during insertion of the insertionpiece into the throat of the patient the insertion piece will positionitself beneath the epiglottis and permit a well controlled upwardslifting motion on the handle piece (102). Angle (148) is preferably 107degrees but can range between 91 and 120 degrees. Angle (148) alsoensures that the handle piece will not strike the chest of the patientduring intubation.

Referring now to FIG. 4 and FIG. 5 (right hand views), FIG. 7(perspective view) and FIG. 8 (left hand view) insertion piece (104)comprises a linear-curved-linear member (150) having a first end (152)and a truncated tip (170). The first end (152) further includes a sidepart (156) that is integral to second end (132) of the hand piece (102).The linear-curved-linear member (150) comprises a first linear portion(155), a curved portion (157) and a second linear portion (166). Thefirst linear portion (155) has an axis (147) that has a positiveinclination from the vertical axis of the hand piece. The curved parthas a predetermined radius (158) adapted for optimum positioning of theETT as it emerges from the delivery channel. The radius can vary but itis at least 3 cm. The curved part can have a single radius or can be acurve with varying radii. The first linear portion (155) extends fromthe first end (152) to approximately mid-way (160) along thelinear-curved-linear member (150). The curved portion (157) extends fromapproximately mid-way (160) to wherein the second linear portion (166)commences.

Referring to FIG. 9, there is shown a top view of the insertion piece(104) of the device (100). The insertion piece is located below the handpiece (102) and commences at end (152) forward of the second end of thehand piece. The insertion piece has a first end (152) and a tip (170). Atubular-shaped channel (190) runs the length of the insertion piece fromfirst end (152) to second end (154—See FIG. 7 and FIG. 8). In thisfigure it is the right side but it can also be the left side. Thechannel has a funnel shaped entry portal (192) for easy insertion of anendotracheal tube as more fully described below. The width (198) of theentry portal (192) is much wider than the tube for easy entry and thennarrows to a width that is slightly narrower than the tube so that tubedoes not prematurely disengage from the channel during intubation.Control of the tube is always maintained by the clinician.

Referring now to FIGS. 7 to 10 where FIG. 10 is an enlarged view of thesecond linear portion (166) of the insertion piece (104). The insertionpiece (104) further comprises a top surface (162) and a bottom surface(164). Portion (166) of the linear-curved-linear insertion device (104)extends from end of the curved portion (157 FIG. 4) to tip (170).Portion (166) has an axis (168), a front truncated tip (170), a firstinwardly angled side edge (172), a second opposite inwardly angled sideedge (174), a third side edge (176) and fourth parallel opposite sideedge (178). Portion (166) also comprises a top surface (179), a bottomsurface (180) and a flange (182) extending around the front truncatededge (170) and the inwardly angled first (172) and second (174) edges.The flange (182) is rounded and adapted to blunt the tip of portion(166) to avoid tissue damage during intubation. The flange also forms anarea of higher pressure against the epiglottis and soft tissue in thearea of the epiglottis when the insertion piece is lifted to expose thevocal cords. This increased pressure helps provide traction on theepiglottis and ensures that the epiglottis is held in place thusreducing the tendency for the epiglottis to slide off the second linearportion, as may be the case with flat bladed intubation devices. Theproblem is especially true when the insertion piece is constructed fromsmooth stainless steel. The flange may optionally include textures whichfurther enhance the grip and control afforded by this feature. The topsurface (162) of the insertion piece (104) including the top surface(179) of the second linear portion (166) are contiguous and comprise araised element (184) located along the centre-line (168). The raisedelement is adapted for stabilization of the device in the midline of thepatient's tongue during intubation by engaging the mid-line groove ofthe tongue (median sulcus Item 52 FIG. 3) in a frictional manner. Theraised element may also be textured to improve its frictional grippingaction on the tongue.

Referring to FIG. 5, the axis (168) of the second linear portion (166)and the axis (147) of the first linear portion (155) intersect at asecond predetermined angle (186). Angle (186) is between 80 and 89degrees. In one example of the device, the predetermined angle (186) isabout 85 degrees. Generally, it is important that the second linearportion of the insertion piece forms a slightly obtuse angle with thefirst linear portion of the insertion piece in order to achieve properepiglottis lift and to help direct the tube through the vocal cords anddown the trachea. Maintaining this range of angles also ensures that tip(170) of the insertion piece (104) will pass beneath the epiglottis ofthe patient during intubation and facilitate epiglottis lift foraccurate guidance of the endotracheal tube between the vocal cords ofthe patient. Portion (166) is preferably 3 cm long but can range from 2cm to 7 cm in length.

Referring now to FIG. 9 and FIG. 11, which is the same as FIG. 5, theinsertion piece (104) includes an open channel (190) located along oneside extending from a first end (152) to a second end (154). The openchannel has a tubular-shaped cross-section so that it will cover atleast 200 degrees of an endotracheal tube inserted into it. The openchannel (190) has an entry portal (192) located at the first end and anexit portal (194) located at the second end for passage of anendotracheal tube (196) as illustrated in FIG. 12. The entry portal(192) is disposed ahead of the handle piece (102) second end (122) foreasy ETT insertion. The entry portal has a flared width (198) largerthan the width (199) of the endotrachael tube for easy tube insertion. Asmall groove (191) about 1 mm deep is located on the lower surface ofthe open channel from the entry portal to the exit portal extendingthroughout the channel of the insertion piece. Most endotracheal tubeshave a small ridge (197) on their outer convex side. This groove (191)is meant to accommodate a slight ridge line (197) often found on theouter contour of the many tubes. The ridge line on the tube functions asa radio-opaque strip, so that it shows up on x-rays. In this example ofour invention it allows further stabilization of the endotracheal tubewithin the channel. The exit portal (194) is located at end (154) belowportion (166). The diameter of the open portion of the delivery channel(190) is slightly less than that of the endotracheal tube throughout itslength to ensure that the tube remains within the channel duringadvancement. The motion of the tube through the channel of the insertionpiece is guided by the clinician's free hand, and following its correctplacement, is disengaged from the open portion of the channel by theclinician's pinching the tube and pulling it away from the channel, tothe right.

The entry portal (192) of channel (190) acts as a ‘tube collectionarea’. The reasoning behind this is that with traditional directlaryngoscopy, the clinician first places the scope in the patient, getsthe view, and then as the next maneuver, picks up the tube and passes itinto the patient's trachea. In this example of our invention, the widecollection area is unique and is designed to similarly enable theclinician to first place the device in to the patient, then place thetube via the wide collection area, without taking his or her eyes offthe view of the vocal cords. Other competing scopes require priorloading of the tube.

A groove (150) is continuous with the channel of the insertion piece andis adapted to provide additional guidance to the tube as it emerges fromthe channel (190) and maintains the tube in a straight orientation forinsertion between the patient's vocal cords. This groove (150) isdisposed on the underside (152) of portion (166) and is tapered from itsrear (154) to its front (156). In one example of the invention theillumination system uses a light guide (126 or 132) to transmit lightfrom an LED lamp located within the hand piece to illuminate theinterior of the throat once the insertion piece is inserted. In anotherexample of the invention there may be two LED lamps (126 and 132) thatprovide direct illumination and are located on the right side of theexit portal (194). The image gathering component (148) of the imageviewing system is further explained below. The terminal components(148,126,132) of these systems (illumination and image viewing) may varyslightly in location but are grouped together within a 10 mm radius andmay be on either side of the exit portal. As further described below,these components are connected to their respective power sources andcontrollers by a bore (See FIG. 15 Item 224) that runs the length of theinsertion piece and into the hand piece. The bore can be easily moldedinto the insertion piece and the hand piece of the body. Although asingle piece body is preferred for ease of manufacture and less cost, amultiple piece mold can be used to accommodate the various bores,inserts and battery magazines illustrated herein. As well, the closeproximity of the one or two lamps to the viewing lens (148) assists inkeeping the lens free of fog and moisture while in the throat of thepatient. The lamps emit sufficient heat to act as a defogging device forthe viewing lens. When the insertion device is made from a suitablethermoplastic material having translucent properties, the illuminationemitted by the LED devices is able to disperse through the insertiondevice providing better illumination of the trachea of the patient onboth sides of the insertion device and permitting more accurate guidanceof the tube between the vocal cords.

Referring to FIG. 14, there is illustrated a side view of theendotracheal tube (196) as it emerges from the second end (194) of theopen channel (190). The curve of the insertion piece, the diameter ofthe open channel and other dimensional constraints ensure that the tubeexits the channel with a small gap (195) between the tube and the tip(170) of portion (166). This width of the gap (195) should be between 2millimeters and 10 millimeters. If the gap is too small, the tube maycatch on the upper portion/anterior commissure of the vocal cords. Ifthe blade tip is positioned above the epiglottis in the valleculla, thetube may impact and down-fold the epiglottis resulting in a failedintubation. If the gap is too large the tube may drop below the vocalcords and enter the esophagus resulting in air being delivered into thestomach instead of the lungs. The interior geometry of the channel ofthe insertion piece creates a ‘3-point fixation’, whereby there are 3points of contact between the tube and the inside the curvature of thechannel of the insertion piece blade. The 3-point fixation dictates howthe advancing tube exits the channel, thus how far away from the tip ofthe insertion piece it will be.

Now referring to FIG. 15, there is shown another example of theinvention (200) comprising a body comprising a cap piece (202), aninsertion piece (206) and a hand piece (204). On the face (208) of thecap piece (202) are mounted a push-button switch (212) and eye-piece(214). Push-button switch (212) is electrically connected to a DC powersource (215) comprising at least one battery (217) and then to at leastone LED lamp light source (218) (see also FIG. 13 Item (126)) locatedadjacent to the second end (220) of the insertion piece (206) andbeneath the portion (221). The light source may also be located in thehand piece (204) and provides illumination by way of a light guide(fiberoptic bundles) that travels through the bore (224) and terminateat the distal end of the device (218) (at the second end (220) of theinsertion piece (206) and beneath the portion (221)). The push-buttonswitch controls the on-off function of the illumination system. Theillumination system provides lighting to support the image viewingsystem and may include but is not limited to the use of incandescent orLED lamps.

The illumination system provides a bright light source sufficient toilluminate the interior of the throat and path to and including thevocal cords and surrounding anatomy during intubation. Electrical wiring(222) for the illumination system is contained within a bore (224) thatruns the length of the insertion piece (206) in order to connect atleast one battery (217) to the lamp(s). Alternatively when the lamp islocated within the hand piece, light transmission occurs by way of fiberoptic bundles that travel within the bore (224) to the distal end (218)of the device.

The eye-piece (214) is optically connected to the distal image gatheringcomponent (216) (See also FIG. 13 Item (148)) located adjacent to thedistal illumination component portal (218) by a fiberoptic member (228)that travels through bore (224) with the illumination system components(222). This combination of image gathering and illumination allows theclinician to view safe passage of the endotracheal tube through thevocal cords into the patient's trachea through the eyepiece.

Referring to FIG. 16 there is shown another example (340) of theinvention comprising a cap piece (342), a hand piece (344) and aninsertion piece (346). Mounted to the face (348) of the cap piece (342)are push-button switch (350) and video display unit (352). Video displayunit (352) is electrically connected (354) to a camera (356) (See alsoFIG. 13 Item (148)) located adjacent to the light sources. In anotherexample of the device the video display (352) is removable from the topcap for placement in a convenient location during intubation andconnected to the camera wirelessly or by means of an extension cord thatcan be inserted into plug (360). The video display unit is powered bythe same source as used to power the illumination system.

Referring to FIG. 17 there is illustrated a representation of what mightbe seen on the display (352). The vocal cords (374) should be seenclearly when the insertion piece is inserted and then lifted verticallyto manipulate the epiglottis and expose the vocal cords. An aimingreticle (372) that mimics the shape of the inlet between the vocal cordsis provided as an aid to the novice user in aligning the insertion piecetip on the vocal cords, both on a left-right and up-down basis, toachieve a smooth and successful intubation. Once aligned the user caninsert the endotracheal tube through the insertion piece and can view itpassing between the vocal cords and therefore entering the trachea.

Now referring to FIGS. 18 and 19 there is illustrated one advantage ofthe invention (FIG. 19) when compared to a prior art device (FIG. 18).

In FIGS. 18 and 19 the vocal cords are shown with wide separation forillustrative purposes. Clinically, they are much closer together. Inaddition this view is from below the cords looking up and therefore theright vocal cord (402) appears on the left side of the FIGS. 18 and 19and correspondingly the left vocal cord (404) appears on the right sideof the FIGS. 18 and 19. Returning to the key challenge of delivering theendotracheal tube with a beveled tip safely between the vocal cords, itis necessary to view FIG. 18. FIG. 18 shows the bottom view of theportion (166) with the tube (400) inserted partially through the exitportal (194) of the insertion device. The tip (170) of the second linearportion (166) is usually below the epiglottis, close to the vocal cords(cross-sectionally represented by circles (402) and (404)) and the tubeis poised to pass between then. The image gathering component (406) mayhave a focal path (408) that is typically focused on the center (410) ofthe blade tip (170). As the clinician aligns the tip (170) to centrebetween the vocal cords the endotracheal tube tip (400) may thereforefollow a path that may result in contact with the right vocal cord (402)as shown by arrow (412) potentially preventing tube passage and damagingthe vocal cord. This problem becomes more severe if the vocal cords arecloser together, as may be the case in some patients requiring emergencyintubation.

Our invention acknowledges the fact that an endotracheal tube has itsleading edge beveled as illustrated in FIGS. 18 and 19. Therefore, theright leading edge extends further forward than the left. This is to aidpassage of the tube during direct laryngoscopy. However, when passing atube using scopes of the type of our invention the right leading edge ofthe tube can catch and hold up on the right vocal fold, thus impedingforward tube passage down the trachea. In this example of our inventionthe lens of the imaging gathering component (406) is designed so that itaims a little to the right of midline. This will result in the image ofthe vocal cords lying to the left of midline. The clinician would then,in the effort to center the view of the cords in the midline, naturallytwist the scope very slightly to the left. This would, in turn, resultin the right leading edge of the tube, as it was advanced, being keptaway from the right vocal fold. In another example of the invention, thesame result can be obtained by having the entire delivery channelproceed very slightly from right to left as it passes down within theinsertion piece.

Referring now to FIG. 19 this example of the invention relies upon animage gathering system (420) with an improved focal path (422) that isangled slightly right of midline and closer to the right vocal cord(402). The slight eccentricity in the focal path will result in anoptical view of the cords offset to the left, which prompts theclinician to twist the tip (170) of the second linear portion (166)slightly to the left to center the cords in the visual field therebyhelping avoid right vocal cord contact as the tube is advanced, asillustrated by arrow (424). It can be appreciated that the imagegathering system (420) can be moved to the other side of the exit portal(194) blade with the same desired effect of alignment between the tubetip and the vocal cords.

Photo A and Photo B illustrate the advantage of using a video displayunit with the aiming reticle as shown in FIG. 19 to ensure appropriatedevice aiming for easy tube passage into the trachea. Once correctlyaligned with the vocal cords, as in Photo B, tube passage should benon-problematic.

Now referring to FIG. 20, there is shown another example of theinvention (500) comprising a body comprising a cap piece (502), a handpiece (504) and an insertion piece (506). In this example, insertionpiece (506) is separable from hand piece (504) by joining means (508).In this example, the insertion piece can be removed for disposal orsterilized for repeated uses. As well, the separable hand piece andinsertion piece permits use of varying component sizes to accommodatepatients of varying size. The joining means is adapted to permitelectrical and optical connections from the insertion piece into thehand piece so that all of the previously described examples of theinvention can be accommodated with this design.

Although the description above contains much specificity, these shouldnot be construed as limiting the scope of the invention but as merelyproviding illustrations of some of the presently preferred embodimentsof this invention. Thus the scope of the invention should be determinedby the appended claims and their legal equivalents.

1. An airway intubation device comprising a cap piece, a hand piece andan insertion piece wherein said cap piece, said hand piece and saidinsertion piece comprise a rigid single body molded from a suitablebiocompatible material having translucent properties.
 2. The device ofclaim 1 wherein the hand piece is ergonomically adapted for left handmanipulation and comprises a first end, a second end, a vertical axis,an oval cross-section for hand clasping, a finger contact portion, apalm contact portion and a thumb contact portion permitting fine controlto be exerted on the device with minimum force.
 3. The device of claim 2wherein said finger contact portion comprises a train of alternatingridges and valleys adapted for placement between a clinician's index,middle, ring and small fingers for even force distribution.
 4. Thedevice of claim 3 wherein said palm contact portion is adapted for fullcontact with a clinician's palm so that manipulative forces can betransmitted to the device through the entire surface of said clinician'spalm.
 5. The device of claim 4 wherein said thumb contact portion isadapted for contact with the side of a clinician's thumb so thatmanipulative forces can be exerted on the thumb contact portion.
 6. Thedevice of claim 5 wherein the insertion piece comprises, from top tobottom, a first linear portion having a first axis, contiguous with acurved portion, contiguous with a second linear portion having a secondaxis; and further wherein, said first axis is inclined in a positivedirection from said vertical axis.
 7. The device of claim 6 wherein saidsecond axis and the vertical axis intersect at a first predeterminedangle.
 8. The device of claim 7 wherein said first predetermined angleis between 91 degrees and 120 degrees.
 9. The device of claim 8 whereinthe first predetermined angle is about 107 degrees.
 10. The device ofclaim 9 wherein the second linear portion comprises a truncated tip, atop surface, a bottom surface and a flange member extending around saidtruncated tip for blunting the truncated tip to avoid tissue damageduring intubation.
 11. The device of claim 10 wherein the insertionpiece further comprises a top surface having a centre-line and a raisedelement disposed along and over said centre-line for controllingmovement of a patient's tongue during intubation by frictional contactwith median sulcus thereof.
 12. The device of claim 11 wherein the firstaxis and the second axis form a second predetermined angle.
 13. Thedevice of claim 12 wherein said second predetermined angle is between 80and 89 degrees.
 14. The device of claim 13 wherein the secondpredetermined angle is about 85 degrees.
 15. The device of claim 14wherein the insertion piece further comprises an open channel having afirst end and a second end, said open channel having a tubular-shapedcross-section providing at least 180 degrees of circumferential coveragefor an endotracheal tube inserted therein.
 16. The device of claim 15wherein the channel has an entry portal adjacent to said first end andan exit portal adjacent to said second end; and wherein said entryportal is wider than said exit portal and said endotracheal tube forease of placement; and wherein, the exit portal includes pinch means tohold the endotracheal tube stationary until acted upon by the clinician.17. An airway intubation device comprising a cap piece, an ergonomicallyadapted hand piece, a linear-curved-linear insertion piece having atruncated tip having a centre point, a channel having a first end and asecond end, said channel disposed within one side of saidlinear-curved-linear insertion piece, an image gathering system, anillumination system and an image viewing system for permitting theclinician to view insertion of an endotracheal tube into a patient'strachea between said patient's vocal cords without contact.
 18. Thedevice of claim 17 wherein said illumination system comprising at leastone LED lamp disposed at said second end of the insertion piece forilluminating the patient's vocal cords and surrounding areas.
 19. Thedevice of claim 17 wherein said illumination system comprises at leastone LED contained within the hand piece and connected by way of fiberoptic cable to an at least one illumination component portal disposed atthe second end of the insertion piece.
 20. The device of claim 17wherein said image gathering system comprises an image gatheringcomponent lens disposed at the second end of the insertion device. 21.The device of claim 20 wherein said image viewing system comprises aneye piece mounted to said cap piece, said eyepiece connected to theimage gathering system by a fiber optic member so that the clinician mayview the patient's trachea during intubation.
 22. The device of claim 20wherein the image gathering system comprises a camera disposed behind atsaid image gathering component lens.
 23. The device of claim 22 whereinthe image viewing system comprises a video display screen mounted to thecap piece and electrically connected to said camera.
 24. The device ofclaim 17 wherein the image gathering means comprises a focal pathpassing to one side of said centre point to prompt appropriate devicepositioning by the clinician so that said endotracheal tube will passbetween the patient's vocal cords without contact.
 25. The device ofclaim 23 wherein the said video display screen comprises an anatomicallycorrect aiming reticle mimicking the patient's vocal cords so thatduring entubation the clinician is able to align the patient's vocalcords with said anatomically correct aiming reticle and guide theendotracheal tube between the patient's vocal cords without contact.